University of Michigan
Department of Pediatrics
Evidence-Based Pediatrics Web Site

Question

• Vaccine safety is a major parental concern today.  Recently a vaccine has been developed to prevent Strep pneumoniae infections in infants and toddlers.  Is this vaccine safe to administer to patients in this age group?

Clinical Bottom Lines

1. A study of 37,868 infants in the Northern California Kaiser Permanente health care system showed an association between this vaccine and an increased incidence of fever and local reactions (erythema, swelling, and tenderness) over the control vaccine.¹
2. This study did not show a significant increase in the number of clinic visits, ER visits, hospitalizations, or deaths related to the vaccine over the control vaccine.
3. The heptavalent pneumococcal conjugate vaccine appears safe for infants and toddlers and has been approved by the FDA for use in these age groups.

Summary of Key Evidence

1. This study was a randomized, double-blinded study.¹
2. 37,868 infants were randomized 1:1 to receive either the pneumococcal conjugate vaccine (study vaccine) or a meningococcal conjugate vaccine (control vaccine).  Each infant received the standard immunizations per routine schedule as well.
3. Ten to 14 % of infants who received the study vaccine developed erythema at the injection site vs. 4 to 10 % of those who received the control vaccine.
4. Nine to 12 % of infants who received the study vaccine developed swelling at the injection site vs. 4 to 7 % of those who received the control vaccine.
5. 14 to 23 % of infants who received the study vaccine developed tenderness at the injection site vs. 12 to 18 % of those who received the control vaccine.
6. 15 to 24 % of infants who received the study vaccine developed fever > 38 C vs. 9 to 17% of those who received the control vaccine.  Most fevers were between 38 and 39 C.
7. The only significant difference reported between the study and control groups in clinic visits was for seizures, in which the control group outnumbered the study group 23 to 11.
8. The only significant differences in the number of ER visits occurred for breath-holding spells (5 for study vaccine vs. none for control vaccine) and cellulitis (1 for study vaccine vs. 7 for control vaccine).
9. Hospitalizations for febrile seizures occurred more frequently in the study group who received the DTwP vaccine than the control group who received the DTwP vaccine; however, this difference was negated when each group received the DTaP vaccine.
10. The only other significant difference for hospitalizations was for elective ones, in which the control group outnumbered the elective group 116 to 87.
11. There were 4 SIDS deaths reported for the study group vs. 8 SIDS deaths reported for the control group, both of which is less than or equal to the incidence of SIDS deaths in the state of California per year (0.5 per 1000 infants).  No other deaths were reported.

Additional Comments

• This study was sponsored by the vaccine manufacturer, Wyeth-Lederle.
• Administering this vaccine at two, four, and six months means giving infants a total of five, four, and four shots, respectively.  Is this going to be acceptable to parents?  How can the current immunization schedule be shuffled around safely to decrease the number of shots to an acceptable number at each visit?

Citation

1. Black S, Shinefield H, Fireman B, et al., and the Northern California Kaiser Permanente Vaccine Study Center Group.  Efficacy, safety, and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatric Infectious Disease Journal, 2000; 19:187-95.

CAT Author: Susan Frangiskakis, MD

CAT Appraisers: John G. Frohna, MD

Date appraised: May 8, 2000